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IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted its third abbreviated new drug application (ANDA) in 2013 to the U.S. Food and Drug Administration (FDA), which brings the Company’s total number of ANDA submissions to eleven.
Jason Grenfell-Gardner, President and CEO of the Company, commented, "Today’s submission brings our total number of abbreviated new drug applications on file with the FDA to eleven which together we believe have a combined addressable market of approximately $250 million based on recent IMS. Our research and development team remains on track to deliver on our expectation to file at least six ANDAs in 2013. We believe that our development pipeline is the strongest organic driver we have to create long term value for our shareholders, and we plan to continue to invest in our research and development efforts to accelerate the growth of our pipeline. We remain focused on the development of topical generic pharmaceutical products and are optimistic about the opportunities in these markets.”
About IGI Laboratories, Inc.
IGI Laboratories is a generic topical pharmaceutical company. We develop and manufacture topical formulations for the pharmaceutical, OTC, and cosmetic markets. Our mission is to be a leading player in the generic topical prescription drug market.
This press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, plans, objectives, expectations and intentions, and other statements contained in this press release that are not historical facts and statements identified by words such as "plan," “believe," "continue" or words of similar meaning. Factors that could cause actual results to differ materially from these expectations include, but are not limited to: our inability to meet current or future regulatory requirements in connection with existing or future ANDAs; our inability to achieve profitability; our failure to obtain FDA approvals as anticipated; our inability to execute and implement our business plan and strategy; the potential lack of market acceptance of our products; our inability to protect our intellectual property rights; changes in global political, economic, business, competitive, market and regulatory factors; and our inability to complete successfully future product acquisitions. These statements are based on our current beliefs or expectations and are inherently subject to various risks and uncertainties, including those set forth under the caption "Risk Factors" in IGI Laboratories, Inc.’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other periodic reports we file with the Securities and Exchange Commission. IGI Laboratories, Inc. does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise, except as required by law.